Axial Spondylarthritis (axSpA)NCT06978374
Ultrasonographic Assessment of Thoracolumbar Fascia in AxSpA and Controls With Trigger Point Evaluation
An observational study of Axial Spondylarthritis (axSpA) and Myofascial Trigger Point Pain (MTrP), run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate whether changes in the thoracolumbar fascia (TLF)-a connective tissue in the lower back-are related to pain and disease severity in patients with axial spondyloarthropathy (ax-SpA), a chronic inflammatory spine condition. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Spondylarthritis (axSpA), Myofascial Trigger Point Pain (MTrP), Ultrasound Exams
- What is being tested?
- Sonographic examination of thoracolumbar fascia, manual examination of MTrP
- Type of treatment
- Injection or infusion
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult male and female participants aged 18 to 65 years, who presented to the Rheumatology outpatient clinics of Ankara University School of Medicine Hospital, including individuals diagnosed with axial spondyloarthritis based on ASAS criteria and healthy controls who provided written informed consent.
Who may be able to join
- Individuals aged between 18 and 65 years
- Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of -SpondyloArthritis International Society (ASAS) classification criteria, or being a healthy control with no known musculoskeletal or systemic inflammatory disease
- Ability to lie in the prone position for ultrasonographic examination
- Willingness to participate in the study
- Provision of written informed consent prior to inclusion
Who cannot join
- History of significant back or lower extremity trauma or orthopedic surgery
- Presence of major spinal deformities (e.g., scoliosis, kyphosis, spinal stenosis)
- History of spinal surgery or spinal fracture
- Known malignancy or spinal infection
- Neurological deficits due to nerve root compression
- Presence of a diagnosed neurological or major psychiatric disorder
Show all 12Show fewer
- Known bleeding disorders
- History of lumbar steroid injection or current use of systemic corticosteroids
- Current pregnancy
- Legal or disability status related to low back pain
- Presence of an acute systemic infection
- Refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Medicine Hospital
Ankara, Mamak, 06100
About this study
Official title: Ultrasonographic Evaluation of Thoracolumbar Fascia Morphology in Axial Spondyloarthropathy and Controls: A Pilot Study With Clinical Assessment of Myofascial Trigger Points
The goal of this observational study is to evaluate whether changes in the thoracolumbar fascia (TLF)-a connective tissue in the lower back-are related to pain and disease severity in patients with axial spondyloarthropathy (ax-SpA), a chronic inflammatory spine condition. The study involves adults diagnosed with ax-SpA and healthy volunteers of similar age and gender.
The main questions it aims to answer are:
Read more
Is the thickness or shape of the thoracolumbar fascia different in patients with ax-SpA compared to healthy individuals? Is there a relationship between changes in the thoracolumbar fascia and the presence of painful muscle trigger points? Researchers will compare measurements in ax-SpA patients and healthy volunteers to see if differences in fascia structure are linked to pain, function, and disease activity.
Participants will:
Undergo a back ultrasound (non-invasive imaging) to assess the thickness and structure of the thoracolumbar fascia.
Be examined for muscle trigger points using gentle manual palpation. Complete questionnaires and assessments on physical function, quality of life, and disease activity.
Read the detailed description
The goal of this observational study is to explore whether structural changes in the thoracolumbar fascia (TLF)-a connective tissue layer in the lower back-are related to pain, stiffness, and disease activity in individuals with axial spondyloarthropathy (ax-SpA), a chronic inflammatory condition that affects the spine and can cause significant back pain and limited mobility. The study also examines whether these changes are linked to myofascial trigger points, which are sensitive or painful spots in the muscles.
This research includes adults diagnosed with ax-SpA, as well as healthy volunteers of similar age and gender who do not have chronic back pain or spinal diseases.
The main questions it aims to answer are:
Do patients with ax-SpA have increased thickness or irregular structure in the thoracolumbar fascia compared to healthy individuals? Is there a connection between fascia changes and the presence of painful muscle trigger points? Are these findings related to the severity of disease symptoms, such as pain, stiffness, physical function, and quality of life? Does the use of anti-inflammatory or immune-modulating medications affect the presence of these muscle trigger points? Researchers will compare ultrasound and clinical findings between ax-SpA patients and healthy volunteers to determine whether structural differences in the fascia can be used as a non-invasive indicator of disease burden.
Participants will:
Undergo a high-resolution ultrasound scan of their lower back to assess the structure and thickness of the thoracolumbar fascia.
Receive a manual examination to check for muscle trigger points in the lower back.
Complete questionnaires related to pain, function, fatigue, and quality of life.
Share information about their medical history, including the use of medications such as non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), and TNF-alpha inhibitors.
- Being tested
- Sonographic examination of thoracolumbar fascia, manual examination of MTrP
- Keywords
- Thoracolumbar fascia, Axial Spondyloarthropatis (axSpA), Myofascial Trigger Point Pain (MTrP), Ultrasound, Sonography
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic examination of thoracolumbar fascia, manual examination of MTrPOther
Patients were positioned in the prone position, with a cushion placed under the abdomen to flatten the lumbar lordosis.
A 14-18 MHz linear transducer was used for ultrasonographic (USG) evaluation, performed with a GE Logiq P5 ultrasound device (Serial No: GE-114118SU3).
The USG probe was placed longitudinally at the L2-L3 intervertebral level, 2 cm lateral to the vertical line connecting the spinous processes on both sides, in order to assess the thoracolumbar fascia (TLF).
| Study group | Role | What they receive |
|---|---|---|
| AxSpA group | This study included individuals aged between 18 and 65 years who were classified as having axial spondyloarthritis (axSpA), including both radiographic and non-radiographic forms, according to the Assessment of SpondyloArthritis International Society (ASAS) classification criteria. Participants with additional health conditions that could affect thoracolumbar fascia (TLF) morphology or spinal biomechanics were excluded from the study. Exclusion criteria included: History of severe back or lower extremity trauma or surgery, Significant spinal deformity (e.g., scoliosis, kyphosis, spinal stenosis), History of spinal surgery, History of spinal fracture, Malignancy or spinal infection, Neurological deficit due to nerve root compression, Neurological or major psychiatric disorders, Bleeding disorders, Previous lumbar steroid injection or current systemic steroid use, Pregnancy, Disability status or ongoing legal process related to low back pain, Presence of acute systemic infection Receives: Other: Sonographic examination of thoracolumbar fascia, manual examination of MTrP | |
| Healthy group | Participants in the healthy control group were age-matched (18-65 years) and selected according to the same exclusion criteria applied to the patient group. Receives: Other: Sonographic examination of thoracolumbar fascia, manual examination of MTrP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Assessment of Thoracolumbar Fascia (TLF) Thickness
Thickness of the thoracolumbar fascia (TLF) will be measured using musculoskeletal ultrasound at the L2-L3 vertebral level, bilaterally.
Unit of measures: millimeters (mm)
Measured: Baseline (Day 1)
Thoracolumbar fascia morphology
The morphology of the thoracolumbar fascia will be evaluated bilaterally as either regular or irregular based on ultrasonographic appearance at the same level.
Unit of Measure: Categorical (Regular/Irregular)
Measured: Baseline (Day 1)
Presence of myofascial trigger points
Presence or absence of myofascial trigger points will be assessed through standardized manual palpation criteria during clinical examination.
Unit of Measure: Binary (Present/Absent)
Measured: Baseline (Day 1)
Secondary outcomes (2)
Correlation between thoracolumbar fascia thickness and presence of myofascial trigger points
A correlation analysis will be performed between thoracolumbar fascia thickness (measured in mm via ultrasound) and the presence or absence of myofascial trigger points (determined by physical examination).
Measured: Baseline (Day 1)
Correlation between thoracolumbar fascia morphology and presence of myofascial trigger points
A correlation will be evaluated between fascia morphology (categorized as regular/irregular on ultrasound) and the presence or absence of myofascial trigger points.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Nov 2020
- Primary completion1 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Axial Spondylarthritis (axSpA)Studies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuzlem Gyuner SIDZHIMLI MD, Ankara University
- Investigators
- Sebnem ATAMAN, Study Chair, Study chair, Ankara University School of Medicine, Department of RheumathologyYuzlem Gyuner SIDZHIMLI, MD, Principal investigator, Ankara University School of Medicine, Department of Physical Medicine and RehabilitationSeçilay GÜNEŞ, Ass Prof, Study director, Ankara University School of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978374
- Sponsor's protocol ID
- AUPMRYGSThesis
- Status last verified
- May 2025
- First submitted
- 3 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical and privacy considerations, as well as institutional policy regarding the handling of sensitive clinical data in non-interventional studies.
Publications
De Coninck K, Hambly K, Dickinson JW, Passfield L. Measuring the morphological characteristics of thoracolumbar fascia in ultrasound images: an inter-rater reliability study. BMC Musculoskelet Disord. 2018 Jun 1;19(1):180. doi: 10.1186/s12891-018-2088-5.
PubMed 29859080Abe H, Hayashi S, Kim JH, Murakami G, Rodriguez-Vazquez JF, Jin ZW. Fetal development of the thoracolumbar fascia with special reference to the fascial connection with the transversus abdominis, latissimus dorsi, and serratus posterior inferior muscles. Surg Radiol Anat. 2021 Jun;43(6):917-928. doi: 10.1007/s00276-020-02668-4. Epub 2021 Jan 12.
PubMed 33438110Boccon Gibod L, Correas G, Godefroy D, Ducellier R, Teyssier P. [Radio-transparent renal calculi and epithelial tumours. Contribution of ultrasound and CT scan to the diagnosis (author's transl)]. Nouv Presse Med. 1981 Oct 31;10(39):3231-2. French.
PubMed 7301552Kondrup F, Gaudreault N, Venne G. The deep fascia and its role in chronic pain and pathological conditions: A review. Clin Anat. 2022 Jul;35(5):649-659. doi: 10.1002/ca.23882. Epub 2022 Apr 27.
PubMed 35417568Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
PubMed 31151377
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Thoracolumbar Fascia Morphology in Axial Spondyloarthropathy and Controls: A Pilot Study With Clinical Assessment of Myofascial Trigger Points
- ClinicalTrials.gov ID
- NCT06978374
- Acronym / sponsor ID
- AUPMRYGSThesis
- Keywords
- Thoracolumbar fascia, Axial Spondyloarthropatis (axSpA), Myofascial Trigger Point Pain (MTrP), Ultrasound, Sonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate whether changes in the thoracolumbar fascia (TLF)-a connective tissue in the lower back-are related to pain and disease severity in patients with axial spondyloarthropathy (ax-SpA), a chronic inflammatory spine condition. The study involves adults diagnosed with ax-SpA and healthy volunteers of similar age and gender.
The main questions it aims to answer are:
Is the thickness or shape of the thoracolumbar fascia different in patients with ax-SpA compared to healthy individuals? Is there a relationship between changes in the thoracolumbar fascia and the presence of painful muscle trigger points? Researchers will compare measurements in ax-SpA patients and healthy volunteers to see if differences in fascia structure are linked to pain, function, and disease activity.
Participants will:
Undergo a back ultrasound (non-invasive imaging) to assess the thickness and structure of the thoracolumbar fascia.
Be examined for muscle trigger points using gentle manual palpation. Complete questionnaires and assessments on physical function, quality of life, and disease activity.
Detailed description
The goal of this observational study is to explore whether structural changes in the thoracolumbar fascia (TLF)-a connective tissue layer in the lower back-are related to pain, stiffness, and disease activity in individuals with axial spondyloarthropathy (ax-SpA), a chronic inflammatory condition that affects the spine and can cause significant back pain and limited mobility. The study also examines whether these changes are linked to myofascial trigger points, which are sensitive or painful spots in the muscles.
This research includes adults diagnosed with ax-SpA, as well as healthy volunteers of similar age and gender who do not have chronic back pain or spinal diseases.
The main questions it aims to answer are:
Do patients with ax-SpA have increased thickness or irregular structure in the thoracolumbar fascia compared to healthy individuals? Is there a connection between fascia changes and the presence of painful muscle trigger points? Are these findings related to the severity of disease symptoms, such as pain, stiffness, physical function, and quality of life? Does the use of anti-inflammatory or immune-modulating medications affect the presence of these muscle trigger points? Researchers will compare ultrasound and clinical findings between ax-SpA patients and healthy volunteers to determine whether structural differences in the fascia can be used as a non-invasive indicator of disease burden.
Participants will:
Undergo a high-resolution ultrasound scan of their lower back to assess the structure and thickness of the thoracolumbar fascia.
Receive a manual examination to check for muscle trigger points in the lower back.
Complete questionnaires related to pain, function, fatigue, and quality of life.
Share information about their medical history, including the use of medications such as non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), and TNF-alpha inhibitors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AxSpA group | – | Other: Sonographic examination of thoracolumbar fascia, manual examination of MTrPThis study included individuals aged between 18 and 65 years who were classified as having axial spondyloarthritis (axSpA), including both radiographic and non-radiographic forms, according to the Assessment of SpondyloArthritis International Society (ASAS) classification criteria. Participants with additional health conditions that could affect thoracolumbar fascia (TLF) morphology or spinal biomechanics were excluded from the study. Exclusion criteria included: History of severe back or lower extremity trauma or surgery, Significant spinal deformity (e.g., scoliosis, kyphosis, spinal stenosis), History of spinal surgery, History of spinal fracture, Malignancy or spinal infection, Neurological deficit due to nerve root compression, Neurological or major psychiatric disorders, Bleeding disorders, Previous lumbar steroid injection or current systemic steroid use, Pregnancy, Disability status or ongoing legal process related to low back pain, Presence of acute systemic infection |
| Healthy group | – | Other: Sonographic examination of thoracolumbar fascia, manual examination of MTrPParticipants in the healthy control group were age-matched (18-65 years) and selected according to the same exclusion criteria applied to the patient group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female participants aged 18 to 65 years, who presented to the Rheumatology outpatient clinics of Ankara University School of Medicine Hospital, including individuals diagnosed with axial spondyloarthritis based on ASAS criteria and healthy controls who provided written informed consent.
Key inclusion criteria (5 listed)
- Individuals aged between 18 and 65 years
- Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of -SpondyloArthritis International Society (ASAS) classification criteria, or being a healthy control with no known musculoskeletal or systemic inflammatory disease
- Ability to lie in the prone position for ultrasonographic examination
- Willingness to participate in the study
- Provision of written informed consent prior to inclusion
Key exclusion criteria (12 listed)
- History of significant back or lower extremity trauma or orthopedic surgery
- Presence of major spinal deformities (e.g., scoliosis, kyphosis, spinal stenosis)
- History of spinal surgery or spinal fracture
- Known malignancy or spinal infection
- Neurological deficits due to nerve root compression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonographic examination of thoracolumbar fascia, manual examination of MTrPPatients were positioned in the prone position, with a cushion placed under the abdomen to flatten the lumbar lordosis. A 14-18 MHz linear transducer was used for ultrasonographic (USG) evaluation, performed with a GE Logiq P5 ultrasound device (Serial No: GE-114118SU3). The USG probe was placed longitudinally at the L2-L3 intervertebral level, 2 cm lateral to the vertical line connecting the spinous processes on both sides, in order to assess the thoracolumbar fascia (TLF). | Other | AxSpA group, Healthy group |
Primary outcome
Ultrasonographic Assessment of Thoracolumbar Fascia (TLF) Thickness
Time frame: Baseline (Day 1)
Thickness of the thoracolumbar fascia (TLF) will be measured using musculoskeletal ultrasound at the L2-L3 vertebral level, bilaterally. Unit of measures: millimeters (mm)
Thoracolumbar fascia morphology
Time frame: Baseline (Day 1)
The morphology of the thoracolumbar fascia will be evaluated bilaterally as either regular or irregular based on ultrasonographic appearance at the same level. Unit of Measure: Categorical (Regular/Irregular)
Presence of myofascial trigger points
Time frame: Baseline (Day 1)
Presence or absence of myofascial trigger points will be assessed through standardized manual palpation criteria during clinical examination. Unit of Measure: Binary (Present/Absent)
2 secondary outcomes
Correlation between thoracolumbar fascia thickness and presence of myofascial trigger points
Time frame: Baseline (Day 1)
Correlation between thoracolumbar fascia morphology and presence of myofascial trigger points
Time frame: Baseline (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Results publication: PubMed 29859080De Coninck K, Hambly K, Dickinson JW, Passfield L. Measuring the morphological characteristics of thoracolumbar fascia in ultrasound images: an inter-rater reliability study. BMC Musculoskelet Disord. 2018 Jun 1;19(1):180. doi: 10.1186/s12891-018-2088-5.
- Results publication: PubMed 33438110Abe H, Hayashi S, Kim JH, Murakami G, Rodriguez-Vazquez JF, Jin ZW. Fetal development of the thoracolumbar fascia with special reference to the fascial connection with the transversus abdominis, latissimus dorsi, and serratus posterior inferior muscles. Surg Radiol Anat. 2021 Jun;43(6):917-928. doi: 10.1007/s00276-020-02668-4. Epub 2021 Jan 12.
- Results publication: PubMed 7301552Boccon Gibod L, Correas G, Godefroy D, Ducellier R, Teyssier P. [Radio-transparent renal calculi and epithelial tumours. Contribution of ultrasound and CT scan to the diagnosis (author's transl)]. Nouv Presse Med. 1981 Oct 31;10(39):3231-2. French.
- Results publication: PubMed 35417568Kondrup F, Gaudreault N, Venne G. The deep fascia and its role in chronic pain and pathological conditions: A review. Clin Anat. 2022 Jul;35(5):649-659. doi: 10.1002/ca.23882. Epub 2022 Apr 27.
- Results publication: PubMed 31151377Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical and privacy considerations, as well as institutional policy regarding the handling of sensitive clinical data in non-interventional studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebnem ATAMAN, Study Chair study chair
Ankara University School of Medicine, Department of Rheumathology
Yuzlem Gyuner SIDZHIMLI, MD principal investigator
Ankara University School of Medicine, Department of Physical Medicine and Rehabilitation
Seçilay GÜNEŞ, Ass Prof study director
Ankara University School of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondylarthritis (axSpA) and Myofascial Trigger Point Pain (MTrP), run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Assessment of Thoracolumbar Fascia (TLF) Thickness (time frame: Baseline (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06978374, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.